PRISM Registry: Pseudobulbar Affect Registry Series

Study Purpose:

PBA is a neurologic condition that is estimated to impact over a million patients and their families in the United States. PBA occurs secondary to an otherwise unrelated neurologic disease or injury, and manifests as involuntary, frequent, and disruptive outbursts of crying and/or laughing. Progress has been made in better understanding this debilitating condition, but much more needs to be done. That's why a new PBA patient registry, PRISM (Pseudobulbar Affect RegIstry Series), has been initiated.

The goal of PRISM is to establish the prevalence and quality of life (QOL) impact of PBA in patients with underlying neurologic conditions including

- Alzheimer's disease

- Amyotrophic lateral sclerosis

- Multiple sclerosis

- Parkinson's disease

- Stroke

- Traumatic brain injury

Because this is an observational registry, it doesn't require you to intervene with any specific treatment or procedure. Your participation allows the PRISM registry to collect and analyze data from your site and also compare it to national numbers captured in the PRISM registry about PBA across all of the major at-risk neurologic populations.

Study Status:

Not recruiting

Disease:

Alzheimer's Disease , Amyotrophic Lateral Sclerosis (ALS) , Multiple Sclerosis (MS) , Parkinson's Disease , Stroke , Traumatic Brain Injury

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Randall Kaye, MD, Avanir Pharmaceuticals

Clinicaltrials.gov ID:

NCT01366027

Neals Affiliated?

No

Coordinating Center Contact Information

Avanir Pharmaceuticals

Aliso Viejo, California, 92656 United States

Full Study Summary:

PBA is a neurologic condition that is estimated to impact over a million patients and their families in the United States. PBA occurs secondary to an otherwise unrelated neurologic disease or injury, and manifests as involuntary, frequent, and disruptive outbursts of crying and/or laughing. Progress has been made in better understanding this debilitating condition, but much more needs to be done. That's why a new PBA patient registry, PRISM (Pseudobulbar Affect RegIstry Series), has been initiated.

The goal of PRISM is to establish the prevalence and quality of life (QOL) impact of PBA in patients with underlying neurologic conditions including

•Alzheimer's disease
•Amyotrophic lateral sclerosis
•Multiple sclerosis
•Parkinson's disease
•Stroke
•Traumatic brain injury

Because this is an observational registry, it doesn't require you to intervene with any specific treatment or procedure. Your participation allows the PRISM registry to collect and analyze data from your site and also compare it to national numbers captured in the PRISM registry about PBA across all of the major at-risk neurologic populations.

Study Sponsor:

Avanir Pharmaceuticals

Estimated Enrollment:

5290

Estimated Study Start Date:

04 / 30 / 2011

Estimated Study Completion Date:

09 / 01 / 2012

Posting Last Modified Date:

04 / 16 / 2014

Date Study Added to neals.org:

06 / 03 / 2011

Minimum Age:

18 Years

Maximum Age:

N/A

Inclusion Criteria:

- All participants must have underlying neurologic conditions known to be risk factors of PBA: Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's Disease, Stroke, and Traumatic Brain Injury.

- The population for this study will be 18 years and over

Avanir Pharmaceuticals

Aliso Viejo, California 92656
United States